Rhode Island Diastolic Dysfunction - Heart Failure
To study the hypothesis that treating patients with underlying diastolic dysfunction with oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices will improve metabolic and echocardiographic diastolic function parameters.
Study Start Date
Estimated Completion Date
- Drug: Kuvan
- Cardiology: Arrhythmias/EP,Diagnostics,Heart Failure,Interventional,Vascular Medicine
- Internal Medicine: Cardiology
- Nursing: Cardiology
- Physician Assistant: Cardiology
- Cardiovascular Diseases
- Heart Failure
Providence VA Medical Center -- 2014-051
Providence VA Medical Center
1. Male and female U.S. Veteran patients over the age of eighteen, with
echocardiographic findings of >= Grade 2 diastolic dysfunction [as per American
Society of Echocardiography guidelines] and
2. Diagnosis of hypertension, diabetes, or heart failure in medical records.
3. Eligible subjects must be ambulatory (not dependent on any ambulatory assist devices
including cane or walker).
1. Any history of documented ejection fraction <50%
2. Significant COPD (defined as oxygen-dependent COPD)
3. Acute coronary syndrome within the past three months defined by EKG changes and
biomarkers of myocardial necrosis (ie. elevated troponin) in the setting of chest
pain or an anginal equivalent)
4. Presence of hypertrophic cardiomyopathy
5. Presence of infiltrative/restrictive cardiomyopathy
6. Echocardiographic evidence of moderate or severe aortic or mitral valve stenosis or
7. Previously diagnosed phenylketonuria
8. End stage renal disease requiring hemodialysis
9. Pre-existing seizure disorder
10. Terminal illness (not including heart failure) with expected survival of one year or
11. Females who are pregnant or breastfeeding. All females of child bearing age will
undergo pregnancy testing prior to randomization.
12. Recent hospitalization within three months.
13. Previous Bioprosthetic and/or mechanical aortic or mitral valves
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Providence VAMC - Providence, Rhode Island||40.1 miles||WenChih Wu MDfirstname.lastname@example.org|